Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...

In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.

Findings indicate that such software can dramatically improve patient safety during surgery. A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General ...

The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to exclude certain medical software functions, including certain decision support software, from the definition ...

On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) software. The January 2026 guidance supersedes the previous, ...

The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF) ...

In this special guest feature, Bradley Merrill Thompson, a partner in the Washington DC office of law firm Epstein Becker & Green and Chairman of the Board of the firm’s consulting affiliate EBG ...

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight ...

Can the inefficiencies, wasted resources and costs associated with delayed or misdiagnosis be tolerated and absorbed in the new healthcare paradigm? As the health system migrates from fee-for-service ...

A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, reveals that computer software that helps inform clinicians’ ...